title: Prospective evaluation of the Amplicor HPV test for predicting progression of cervical intraepithelial neoplasia 2.
abstract: OBJECTIVE
  The aim of this study was to evaluate the clinical performance of the Amplicor HPV test, which detects 13 high-risk human papillomaviruses (HR-HPV), and to determine the association between consistent HR-HPV infection and progression of cervical intraepithelial neoplasia (CIN) 2 to CIN3.
  
  
  METHODS
  This multi-institutional prospective study enrolled 122 women diagnosed with CIN2 by central pathological review. Subjects were tested at study entry and every 6 months over a 24-month period by cytology, Amplicor HPV test and colposcopy. Central pathological review was performed at the end of the study or if CIN progression was suspected.
  
  
  RESULTS
  Ninety-three of the 122 participants completed all tests in the study and were included in the analysis. HR-HPV was detected in 87/93 (93.5%) participants at study entry. Twenty-four of the 87 HR-HPV-positive participants progressed to ≥CIN3, compared with none of the six participants who were HR-HPV-negative at study entry. The positive predictive value, negative predictive value, sensitivity and specificity of the Amplicor HPV test at study entry for predicting ≥CIN3 progression were 27.6%, 100%, 100% and 8.7%, respectively. Sixty-two participants were HR-HPV-positive from study entry through to study completion, 24 of whom progressed to ≥CIN3. None of 31 participants without continuous HR-HPV detection progressed to ≥CIN3. For continuous HR-HPV detection, the positive predictive value, negative predictive value, sensitivity and specificity of the Amplicor HPV test were 38.7%, 100%, 100% and 44.9%, respectively.
  
  
  CONCLUSIONS
  All participants who progressed to ≥CIN3 were continuously HR-HPV-positive. The Amplicor HPV test thus demonstrated a good performance for predicting CIN3 progression.
authors.affiliation: Department of Gynecology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime 791-0280, Japan. tnogawa@shikoku-cc.go.jp
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Nogawa
authors.forename: Masamichi
authors.initials: M
authors.lastname: Hiura
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Tanaka
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Saito
authors.forename: Reiko
authors.initials: R
authors.lastname: Furuta
authors.forename: Kayoko
authors.initials: K
authors.lastname: Watanabe
authors.forename: Tsunekazu
authors.initials: T
authors.lastname: Kita
authors.forename: Kaichiro
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Mikio
authors.initials: M
authors.lastname: Mikami
authors.forename: Ken
authors.initials: K
authors.lastname: Takizawa
mesh_terms: D000328:Adult; D052685:Alphapapillomavirus / Q000302:isolation & purification*; D015331:Cohort Studies; D003127:Colposcopy; D018450:Disease Progression; D005260:Female; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000503:physiopathology / Q000821:virology; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000503:physiopathology / Q000821:virology
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: Amplicor HPV test; cervical intraepithelial neoplasia progression; cervical intraepithelial neoplasia regression; continuous infection; high-risk human papillomavirus